FDA Drug recall D-0027-2026
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-6…
- FDA Drug
- Class II
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class II recall of Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-6… by Amerisource Health Services, citing CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the i….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0027-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-09 |
| Published | 2025-10-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amerisource Health Services |
| Distribution | US |
Product
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
Reason
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Identifiers
| code_info | Lot #: 1017392, Exp. Date 01/31/2026; 1017415, Exp. Date 12/31/2025. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0027-2026%22
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